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Use of Radiomics in the Evaluation of Bone Quality After Alveolar Ridge Preservation

NCT07814092 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-10-01
Last updated
2026-09-10

Condition(s) studied

Alveolar Bone Preservation

Investigational drug(s) / intervention(s)

Alveolar ridge preservation

Alveolar ridge preservation: Following a minimally traumatic tooth extraction performed on patients enrolled in the study according to the inclusion criteria, thorough alveolar debridement is carried out, and the thickness of the residual buccal bone wall is measured. Subsequently, a classic, well-documented alveolar ridge preservation (ARP) technique is performed. This procedure involves completely filling the post-extraction socket with a xenograft biomaterial, which is then covered with a resorbable collagen membrane to prevent graft dispersion and promote healing by second intention. After a 6-month healing period, a bone biopsy core is harvested using a dedicated trephine drill, immediately followed by the simultaneous placement of the dental implant. CBCT scans are performed after 6 months, and a comparison between histomorphological and radiographic outcomes is performed.

Study summary

Bone regeneration techniques using biomaterials are commonly used in dentistry. These include alveolar ridge preservation, sinus lift, and bone ridge augmentation, which are safe procedures to maintain or restore bone for future dental implants. These surgical interventions utilize specific materials following well-defined guidelines. However, to truly understand how much new bone has formed, a specific tissue analysis called histomorphometry is required, which entails analyzing the bone that will be removed during implant placement.

To simplify these evaluations, new techniques are being studied. One of these is radiomics, an approach that analyzes medical images (such as radiographs or CT scans) by searching for details that cannot be seen by the naked eye. The goal is to create predictive models that assist doctors in their decision-making. This study aims to evaluate the quality of bone regeneration using radiomics, analyzing radiographic images taken 6 months after the regeneration procedure. The collected data will be compared with the histomorphometry results and used to train advanced artificial intelligence models. The ultimate objective is to create a large database that allows doctors to evaluate post-regeneration images without having to resort to invasive sampling.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Age between 18 and 75 y.o. * ASA \< 3 * Single-rooted teeth with indication to extraction * Sufficient bone height to permit standard-length implant placement (≥ 8.5 mm) * Presence of healthy oral mucosa with at least 3 mm of keratinized tissue * Presence of all socket walls * Buccal bone thickness \< 1 mm * Periodontal health or stability * Informed consent signed Exclusion Criteria: * General contraindication to oral surgery * Inflammatory or autoimmune diseases * Medical history of neoplastic pathology treated with radio- and/or chemotherapy in the last five years in the head and neck district * Medical history of antiresorptive, antiangiogenetic or high dosage corticosteroideal therapy * Uncontrolled diabetes (HbA1c \> 7%) * Allergy to porcine collagen * Pregnancy * Missing of compliance * One or more missing post-extractive socket walls * Extraction of adjacent teeth in the 6 months following ARP

Primary outcome measure(s)

  • Radiomic features — perioperatively
    The primary outcome of this study is to evaluate the existence and predictive value of radiomic features derived from pre-operative CBCT scans. These digital imaging features will be correlated and compared with histomorphometric outcomes obtained from the bone biopsy cores harvested during the simultaneous implant placement procedure

Trial sites (1)

FacilityCityRegionStatus
SC Clinica di Chirurgia Maxillofacciale e Odontostomatologia Trieste Trieste
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07814092 on ClinicalTrials.gov ↗ ← All trials in Italy